BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 11810774 · Received May 12, 2021

    Report

    Report Number
    3003152976-2021-00258
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    March 15, 2021
    Report Date
    May 27, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-04-27 H6: INVESTIGATION SUMMARY ONE SAMPLE WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A LEAKAGE PAST THE STOPPER RIBS COULD NOT BE OBSERVED AS THERE WAS NO LIQUID WITHIN THE SYRINGE. THE PRODUCT WAS DISASSEMBLED FOR FURTHER INSPECTION, THERE WAS NO DAMAGE OR MOLDING DEFECTS NOTED IN THE PLUNGER ROD OR OTHER COMPONENTS THAT COULD HAVE CAUSED A LEAK AND THE STOPPER WAS VERIFIED TO BE PROPERLY ASSEMBLED ONTO THE PLUNGER ROD. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE LOT 2010097, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES, INCLUDING LEAKAGE TESTING TO VERIFY THE STOPPER SEAL. RESULTS WERE REVIEWED FOR THE LOT 2010097 AND NO ISSUES WERE IDENTIFIED. THE RETURNED SAMPLE UNDERWENT THESE SAME TESTS AND PRODUCT WAS FOUND TO MEET REQUIRED SPECIFICATION. BASED ON THE QUALITY TEAM'S INVESTIGATION AND SAMPLES EVALUATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES LEAKED PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "ON MARCH 15, LEAKAGE PAST STOPPER, OCCURRED 3 TIMES. IT WAS DECIDED TO WITHDRAW THE WHOLE BATCH. NON CONSEQUENCES FOR THE PATIENT."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES LEAKED PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM(B)(6) TO ENGLISH: "ON MARCH 15, LEAKAGE PAST STOPPER, OCCURRED 3 TIMES. IT WAS DECIDED TO WITHDRAW THE WHOLE BATCH. NON CONSEQUENCES FOR THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710675 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2010097

    Patients

    Seq Age Sex Outcome Treatment
    1